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Rulemaking Process

The Informal Rulemaking Process

The summary that follows was prepared to help the public better understand how the rulemaking process works so that you may more effectively participate in it. We prepared it particularly for individuals, small businesses, and others who do not participate in the process on a regular basis. We want to stress that this web page provides only a brief summary – and one that we attempted to keep simple – of what we believe are the important elements in the process. It should not be relied on as a legal document.

In our Rulemaking Requirements document, we provide hyperlinks to give you easy access to the statutes, executive orders, guidance documents, memoranda, etc. that contain the actual legal requirements or provide guidance on the process.

Rulemaking is a process for developing and issuing rules (rules are also referred to as “regulations”). The process can lead to the issuance of a new rule, an amendment to an existing rule, or the repeal of an existing rule.

There are basically three types. The legal distinctions are not always clear, and an agency document or statement can contain more than one kind of rule. The three basic types are:

Legislative (sometimes called “substantive”) Rules. These are rules that implement a statute. They have the force and effect of law; that is, they are legally binding on the agency, the public, and the courts. For example, such a rule might say: “you must not operate your aircraft within 20 miles of a thunderstorm.”

Non-legislative Rules. These rules are often referred to as “guidance.” (More information on guidance documents at DOT can be found elsewhere on this Web site.)

a. Interpretive Rules. These tell the public what the agency thinks the statute and the rules the agency administers mean. For example, the agency might tell you how it defines “thunderstorm.”

b. Policy Statements. These tell the public how the agency plans to exercise a discretionary power. For example, the agency might tell you that, because of a series of accidents, it plans to place enforcement emphasis on its “thunderstorm” rule.

3. Management and Procedural Rules.

a. Management or Personnel. These involve the running or supervising of the agency’s business. They concern the agency and do not affect the public

b. Organization, Procedure, or Practice. These describe the agency’s structure and functions and the way in which its determinations are made.

An agency cannot issue a legislative rule unless it is provided the authority to do so by statute. The statutory delegation can range from broad discretionary authority to a very specific mandate. For example, Congress could delegate to DOT the authority to set minimum safety standards for the manufacture of automobiles that will be sold in the United States. Alternatively, the statute could mandate that DOT require airbags in all motor vehicles, that those airbags meet standards specified in the statute, and that the airbags be installed in all motor vehicles manufactured after a specified date. Between these two extremes, DOT may be delegated different levels of discretion. For example, a statute could mandate that DOT issue a final rule to decrease the number of fatalities and injuries occurring in frontal collisions involving motor vehicles. Or the statute could mandate that DOT require airbags in all motor vehicles but give DOT the discretion to determine the specific standards the airbags must meet and the deadline by which they must be installed.

There are many reasons why an agency may decide to initiate the rulemaking process. The major reasons for DOT agencies fit mostly in the following categories:

Statutory mandate. Congress may specifically require a rule or at least the initiation of the rulemaking process – sometimes with a deadline.

Agency identification of a problem. To the extent an agency has discretion to decide whether to issue a rule, it may identify the need to initiate the rulemaking process in a variety of ways, including the following: We may identify a problem as a result of inspectors’ reports or general agency oversight. For example, we review accident reports or data that may show an increasing safety problem with motor vehicle side collisions or leaks of hazardous materials during transportation. Investigations of accidents may indicate a manufacturing problem that needs to be addressed. We may have difficulties enforcing existing rules, and this may provide evidence of a need to modify the rules. Requests for interpretations or exemptions may demonstrate that a rule needs to be clarified or modified. Finally, changes in technology may justify a change to a rule. For example, new technology may warrant modifying existing rules to permit the use of new materials. The accessibility of the Internet may justify changing reporting requirements to permit electronic filing.

Petition for rulemaking. The public has the right to petition an agency to issue, modify, or rescind a rule, and we may agree on the need for action.

NTSB, GAO, IG, or similar recommendations. Recommendations for rules may come from the National Transportation Safety Board (NTSB), the Government Accountability Office (GAO), the DOT Inspector General (IG), or special commissions or other bodies asked by Congress or the President to develop recommendations on particular issues.

Agencies may use risk assessments – an analytical tool for determining the probability of a problem occurring (e.g., an accident) and the probability of the problem causing harm (e.g., personal injuries) – to help it determine whether to initiate rulemaking and perhaps which rulemakings need priority attention.

Before deciding to start the rulemaking process, an agency evaluates possible alternatives. For example, we evaluate whether the problem might be fixed without the issuance of a rule, through what is often referred to as “marketplace incentives.” For example, we look at whether consumer reactions to a problem will result in a manufacturer making changes to fix the problem. We may also consider whether there are less burdensome alternatives than requiring such things as changing a manufacturing process or an operating procedure; for example, we may decide that requiring the disclosure of information on or labeling a product would achieve the agency’s objective. We may also evaluate a range of possible substantive alternatives to fixing the problem. For example, we might assess whether we should require replacement of a part or more frequent inspections of it. Whenever possible, agencies try to use performance standards rather than design standards. The latter would prescribe a specific fix, such as half-inch thick steel plating. The former sets a standard or objective that must be met. For example, if a crash test with dummies is required, the test instruments in the dummies must show that injuries did not exceed a specified level. The manufacturer can meet the performance standard through whatever means it deems best.

Agencies use economic analyses (sometimes referred to as benefit-cost analyses, regulatory impact analyses, or regulatory evaluations) to help them determine the best alternative and whether the benefits of the rule would justify its costs.

Unless otherwise indicated, this summary briefly describes the process for issuing legislative rules – those that are legally binding.

Administrative Procedure Act. The Administrative Procedure Act (APA) sets forth the basic requirements for “informal rulemaking,” the process generally used by agencies to issue legislative rules. There are numerous other statutes, executive orders, or agency rules that may impose additional requirements. For example, agencies have the discretion to hold public hearings or meetings, but some statutes may require them for particular rulemakings. Other statutes may require special analyses under particular circumstances.

NPRM. The informal rulemaking process, which often is referred to as “notice-and-comment rulemaking,” requires that an agency first issue a notice of proposed rulemaking (NPRM) and provide an opportunity for public comment on the proposal before it can issue a final rule. There are exceptions to the requirement for notice and comment. Some agency rulemakings are completely exempted. Other rulemakings may be exempted for “good cause” (“impracticable, unnecessary, or contrary to the public interest;” e.g., for such things as “emergencies”).

The NPRM must have a preamble, but proposed rule text (the “you must not operate your aircraft within 20 miles of a thunderstorm” type language) is optional. The DOT agencies rarely, if ever, omit the proposed rule text. The NPRM also includes such information as the deadline for comments, how and where to file comments, and people to contact for information about the proposal.

The preamble explains the need and the authority for the proposed rule, including a discussion of any statutory constraints. It also explains any rule text or subjects and issues involved. This would include how the agency chose its proposed solution to the problem or need for the rule. For example, it may explain the safety data that justifies the proposed rule and applying it to certain individuals but not to others. The preamble will also often contain summaries of or the actual analyses the agency has prepared for the proposal (e.g., the risk assessment and the economic analysis). Although the public may comment on anything in the proposal, including the agency’s analyses, the agency may include specific questions on which it particularly wants public comment and data.

NPRM publication. When an agency issues an NPRM, it is normally published in the Federal Register, which is like a “legal newspaper” for the Federal government. If it is not published in the Federal Register, the agency must personally serve all affected persons with a copy. This may be done when, for example, a rule only applies to the owners of a particular aircraft, and the owners are registered with the issuing agency and easily served.

Public comment period. Generally, agencies will allow 60 days for public comment. Sometimes we provide much longer periods. We may also use shorter periods where we can provide justification for them. The public may also request more time; if you provide justification, that will help us make a decision on whether to extend or reopen the comment period. Agencies also may consider late-filed comments, to the extent their decisionmaking schedule permits that; commenters should, however, try to meet the published deadline, since there is no certainty their late-filed comments will be considered. Agencies usually provide information about whether they will consider late-filed comments in the proposed rule and/or their procedural rules.

Public docket. The NPRM is also placed in the public docket for that rulemaking. The rulemaking docket is the file in which DOT places all of the rulemaking documents it issues (e.g., the NPRM, hearing notices, extensions of comment periods, and final rules), supporting documents that it prepares (e.g., economic and environmental analyses), studies that it relies on that are not readily available to the public, all public comments related to the rulemaking (e.g., comments that may be received in anticipation of the rulemaking, comments received during the comment period, and late-filed comments), and other related documents. Although it is our policy to discourage them outside of any public meeting or hearing, we sometimes receive substantive oral communications (sometimes referred to as “ex parte” contacts) concerning a rulemaking; if we do, it is our policy to prepare summaries of those public contacts and place them in the docket.

The public dockets for DOT and other executive branch agency rulemakings can be found at Regulations.gov. That site is searchable by docket number, among other things, and the docket number may be found at the beginning of the NPRM. The DOT agencies use the electronic, Internet-accessible dockets at Regulations.gov as their complete, official-record docket; all hard copies of materials that should be in the docket, including public comments, are electronically scanned and placed in the docket.

Public comments. Agencies may receive anywhere from no comments to tens or hundreds of thousands of comments or more. They can be brief one-line or one-paragraph comments, or they may contain thousands of pages with detailed analysis. We at DOT have found that public comments can be very helpful. We want public comment. We recognize that we do not have all the answers, that the public may identify a better way for us to achieve our objective, and that they may point out problems with our proposal that we did not see. Our rules are improved through public participation.

At the same time, we note that public commenters sometimes make assertions without including data to support them. They may contain arguments or data that conflict with those provided by other commenters. They may be vague or unclear. They may state a position without providing an explanation. While the number of commenters who support or oppose a particular proposal is important information, the agency’s decision cannot be based on as simple tally of “votes.” Pursuant to the APA, the agency’s decision has to be reasonable; we have to provide a basis for our decision and show how our rule will achieve its purpose. Based on our experience, we have developed guidance on how the public can provide effective comments, which can be found elsewhere on this web page.

Logical outgrowth test. The APA notice-and-comment process recognizes that changes may be made to the proposed rule based on the public comments received, but the courts have required that any changes made in the final rule be of a type that could have been reasonably anticipated by the public – a logical outgrowth of the proposal. If the “logical outgrowth test” is not met, we would need to provide a second notice with an opportunity for public comment on the changes.

The final rule. After the comment period closes and the agency has reviewed the comments received and analyzed them, we decide whether to proceed with the rulemaking we proposed, issue a new or modified proposal, or withdraw the proposal. Before reaching our final decision, we will make any appropriate revisions to the various supporting analyses we prepared for the NPRM.

Any final rule must include a preamble and the rule text. The preamble includes a response to the significant, relevant issues raised in public comments, and a statement providing the basis and the purpose of the rule. (We respond to all public comments at one time, in the preamble to the next rulemaking document after the proposal, such as the final rule or a withdrawal of the proposal. We do not respond to public comment by letter, email, or other individual means.) The response to public comment does not have to be to each commenter; similar comments may be grouped together with an opening statement such as “several commenters suggested that…” or the commenters may be referred to by name. The response also does not have to cover relatively minor comments, such as editorial suggestions, although agencies may make general statements, such as “several editorial changes were made at the suggestion of commenters.”

Final rule publication. The final rule is published in the Federal Register or personally served on affected interests. In addition, a copy is placed in the rulemaking docket along with the final version of any supporting documents. The Office of the Federal Register, on a rolling, annual basis, updates the Code of Federal Regulations (CFR) to reflect the additions, changes, or rescissions, made by the rule text. The CFR contains all Federal agency rules currently in effect as of the date of its publication.

Effective date. A final legislative rule cannot be made effective in less than 30 days after publication, unless it is granting an exemption, relieving a restriction, or for “good cause,” which includes such things as emergencies. Sometimes agencies will set implementation or compliance dates that are later than the effective date of the rule. This may be because the rule is being implemented in stages following its effective date, because the agency may want to allow compliance with the new rule before it is required, or for other reasons.

Exemptions. Individuals or entities such as businesses can petition an agency for an exemption from a final rule. We may grant it, if we find unique circumstances not considered during rulemaking that we believe justifies the exemption. We may attach conditions to the exemption.

Agencies may take steps in addition to the minimum requirements of the APA. We generally take these extra steps to increase or improve the opportunities for public participation and to obtain that participation very early in the development process. The principal, additional steps taken by DOT agencies are the following:

ANPRMs. We may use an Advance Notice of Proposed Rulemaking (ANPRM) prior to the issuance of an NPRM. We use them to get early public participation for a variety of reasons, including when we –

Want comments on how to solve a problem before making a proposal.

Have identified a wide range of alternatives and want to narrow the choices before making a proposal.

Need additional information to help analyze the problem and its solutions.

Requests for public comment. This document may be very similar to an ANPRM. We often use it to get comment or data on more limited issues.

SNPRMs. We may use a supplemental NPRM (SNPRM) when we want public comment on a new or modified proposal. This step is especially valuable if we have concerns over whether the changes to the proposal could be issued as a final rule under the logical outgrowth test. Even if another round of comment on the proposals is not required, we may seek additional comment to make sure we understood the comments and responded appropriately. We also could use an SNPRM if we received new information or identified changing circumstances.

IFRs. We may issue an interim final rule (IFR) in situations where we have the authority to issue a final rule, but we want an additional round of public comment on all or part of the rule. We will review the comments we receive, do any additional analysis that is necessary, and then decide whether to modify or revoke the IFR or issue it as a final rule. Sometimes we will use an IFR to get comment on the final rule after it goes into effect, so that the comments can reflect experience under the rule.

Public meetings or hearings. We may use public meetings or hearings before or after a proposal is issued for a variety of reasons. Public meetings allow us to ask questions. They allow for interaction among participants with different views on the issues involved, and they provide a better opportunity for members of the public who believe they are more effective making oral presentations than submitting written comments. Agencies are limited in the number of hearings they can hold by their resources.

Reply comments. We may allow the public to reply to comments submitted by others for a specified time period after the close of the regular comment period. We would announce any reply comment period in the proposed rule or by a subsequent notice.

Negotiated rulemaking. Under the negotiated rulemaking process, we may decide to convene a committee with representatives of the interests that might be affected by a rule and an agency representative. We ask the committee to negotiate a proposed rule. If the agency head approves the proposal, it would be published under the APA informal rulemaking procedures. After the comment period closes, the committee would review any comments and make recommendations to the head of the agency on whether to modify, reject, or publish the proposal as a final rule.

DFRs. Some DOT agencies have issued rules that describe how and for what rulemakings they may use direct final rules (DFRs). This is a streamlined rulemaking process in which the agency only issues a DFR when it determines that it is unlikely that the DFR would receive any comments in opposition during the time set aside before the rule goes into effect. If the agency does receive a negative comment, it would withdraw the DFR; if it decides that a final rule is still necessary, the agency would have to first issue an NPRM under the APA notice-and-comment requirements.

Electronic rulemaking. We are taking increased advantage of electronic technology to increase the opportunities for more effective public participation in rulemaking. For example, one DOT agency has used “chat rooms” during the comment periods on its rulemakings to allow more interchange among commenters.

Agency staffs generally have very good, informal, working relationships with staff from other agencies that have related responsibilities. For example, DOT staff is in regular contact with the Environmental Protection Agency on environmental issues and the U.S. Department of Justice on issues involving access for disabled persons. We also have formal requirements for coordination. For example, pursuant to DOT procedures, we generally categorize rulemakings as significant or nonsignificant. Significant rules are essentially those that are likely to have high benefits or costs or are potentially controversial. If proposed or final rules are significant, other DOT agencies, the Secretary of Transportation, and, pursuant to executive order, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) must review them before they can be issued. Pursuant to another executive order, the Small Business Administration’s (SBA) Chief Counsel for Advocacy must review proposed and final rules anticipated to have a significant economic impact on a substantial number of small entities before they can be issued; if we have questions about the impact of our proposals on small entities, we will often discuss these issues informally with this office earlier in the rulemaking process. There are other statutes and executive orders that may require coordination with other agencies in specific circumstances.

Under the Congressional review provisions in the Small Business Regulatory Enforcement Fairness Act, agencies must submit all final rules to Congress before they can take effect. After submission, Congress can begin a process to overturn the rule. Congress can also use a variety of processes as part of its oversight of agency action, including holding hearings or informal meetings, issuing reports, or adopting legislation.

Under the APA, a rule can be challenged in court because it is arbitrary, capricious, an abuse of discretion, illegal, unconstitutional, in excess of statutory authority, or the agency failed to follow legal procedures. The agency head can also be sued to “compel action unlawfully withheld or unreasonably delayed.” If a court does set aside an agency’s rule for one of these reasons, if often sends the matter back for further consideration by the agency. Other statutes may provide specific authority to sue particular agencies for other reasons.

An agency may take a variety of actions after it issues final rules to help regulated entities and others comply with the rules. We may issue guidance material providing interpretations and agency policy on our own initiative, in response to public requests, or in response to a statutory mandate. The guidance may include training material that might be provided in a variety of formats (e.g., hard-copy manuals and CDs). Much of this material is available through agency Web sites.

We may also conduct inspections, review records or reports, and take other steps to ensure regulated entities understand and are complying with our rules. We may follow this up with a meeting with the regulated entity to tell it what fixes are necessary, or we may identify a problem with the clarity of the rule and address that with changes to the rule. Our objective is to help our regulated entities achieve compliance with our rules. If necessary, however, the agency may take enforcement action against a noncompliant, regulated entity.

The DOT prepares a number of reports to help the public learn about the substance and status of our rulemaking activities:

Report on DOT Significant Rulemakings. At the beginning of each month, we post a report on this website that provides a summary and the status for all significant rulemakings that DOT currently has pending or has issued recently. More information on this report can be found at the above link, including information on how to receive email notifications of the report.

Report on Effects of DOT Rulemakings. The public can generate a separate report on this Web site for each of 21 possible, different effects of DOT’s current rulemakings (e.g., effects on small entities or on state and local governments). More information on these reports can be found at the above link.

The DOT’s Regulatory Agenda.Twice a year, as part of a Governmentwide effort, DOT publishes an Agenda of all of its rulemaking activity. The Agenda includes brief descriptions of each rulemaking, its current status, and a schedule for next actions. It is published in Federal Register and made available on the Internet.

In addition to these regular reports, DOT agencies will sometimes issue press announcements, post information on their specific websites, and take other actions to provide notice and information to interested persons.

We prefer that comments be submitted electronically. It is easier for us to enter them in the docket that way. It is also easier for us and the public to search the documents for information. In addition, it will make it easier to use computer software to help us and the public sort through comments, organize the comments by subject, and do other things that allow more effective use of the comments. We recognize that not everyone has easy internet access, so we do not require electronic submission. You may send comments identified by Docket Number using any of the following methods:

Hand Delivery or Courier: Bring comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Please note that we will post all comments we receive, without change, to Regulations.gov, including any personal information you provide. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received in any of our dockets, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). You may review the Department of Transportation's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://DocketsInfo.dot.gov.

To read rulemaking or background documents or comments received, you may go to Regulations.gov at any time and follow the online instructions for accessing the docket. Alternatively, you may go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

If you have submitted your comments electronically, it is not necessary to submit a hard copy. It is also not necessary for you to submit your comments more than once. Doing either of these things may result in cluttering up the docket with duplicate entries. Finally, you should follow the instructions for submission to the docket; while we make every effort to ensure that all comments are placed in the docket regardless of how or where they are received, if you submit your comments to a departmental official or office other than as noted above, the person receiving them may not know to send them to the docket.

We want your comments. We know we do not have all the answers or know about all of the possible solutions to a problem. To the extent you provide us with good comments, you will enhance our knowledge of the issues, and help us make better rulemaking decisions. We encourage you to challenge our interpretations; applications of data and research; factual assumptions; analytical methodologies; factual, technical, and policy conclusions; practicability assessments; and assessments of the benefits and other impacts of the proposal. We want you to suggest reasonable alternatives to our proposals.

We have asked professionals who review and respond to public comments from throughout DOT for their suggestions on how the public can provide more effective comments. The following list is intended to provide helpful suggestions on how to make your comments more effective; they are not mandatory requirements.

Typewritten documents. We prefer typewritten documents; otherwise the reviewer may not be able read your handwriting. We do not require this, however, because we recognize that everyone may not have access to a typewriter or computer.

Electronic submissions. We prefer that comments be submitted electronically. It is much more efficient for us to enter them in the docket that way. It is easier for us and the public to search the comments for information. It will also make it easier to use computer software to help us and the public sort through comments, organize the comments by subject, and do other things that allow more effective use of the comments. We recognize that everyone does not have easy internet access, so we do not require electronic submission.

Docket ID. You should identify the docket number for the rulemaking document on which you are commenting. The docket number is provided near the very top of the rulemaking proposal. You should also provide other identifying information, such as the RIN (Regulation Identification Number), the title of the rulemaking, or the Federal Register date and page number.

Agency questions. We want your comments on any part of the proposal on which you wish to comment. However, we often ask questions or raise issues in rulemaking proposals on subjects where we especially need more information. Please answer as many as you can.

Organized comments. We sometimes ask you to organize your comments under specific headings or by specific sections in the rulemaking proposal; please try to do so. It will help the public and the agency review the comments more easily and effectively.

Clear explanation and support for views. You should explain your views and reasoning as clearly as possible; provide the basis for your assumptions; and provide empirical evidence or test data, wherever possible, to support your views. By supporting your arguments, you are more likely to persuade us to accept them. If you do not, and we do not have separate data to support your submission, we cannot rely on it. We, the agencies, are required to provide the basis for our final decisions.

Alternatives. You should provide specific alternatives to the proposed rule, including rule text, to help us ensure that, if we agree with your concerns, we can effectively implement your suggestions. In addition, you should provide an analysis of how your alternative(s) would be more effective than the agency’s proposal.

Basis for calculations. You should explain the basis for and the calculations you used in developing any estimates regarding the costs of compliance or the benefits of our proposals or your alternative(s). If you do not, and we cannot determine how you arrived at the estimates you provided, we cannot rely on them. We must be able to reproduce your results.

Examples of concerns. You should provide specific examples to illustrate your concerns. Real world examples or possibilities can help us better understand those concerns.

Statutory limitations. In preparing your comments, you should consider the requirements and limitations of the statutory authority under which the agency is making its proposal. You may be objecting to a proposal over which the agency has no discretion; the agency may be required to issue a final rule with that provision. You may also be proposing an alternative that the agency has no authority to implement.

Your questions. If you have questions – if you do not understand a part of the proposal – you may ask for help. At the beginning of the rulemaking proposal, the agency provides a person for you to contact if you need more information. Although the agency can answer your questions about the proposal’s meaning, it cannot take comments from you on the proposal through these means.

Deadline. You should comply with the deadline for submission of comments. The deadline for comments is provided at the beginning of the rulemaking proposal.